Dementia With Lewy Bodies - Infinitome

Dementia With Lewy Bodies Clinical Trial

Official title:

Connectomic Analysis in Dementia With Lewy Bodies: A Potential Diagnostic Imaging Biomarker

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04773041
• Other study ID #: A21-037
• Status: Completed
• Start date: April 27, 2021
• Est. completion date: June 19, 2023

Study information

• Verified date: October 2023
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Dementia with Lewy bodies (DLB) is the second most common cause of dementia and is associated with parkinsonism, hallucinations, and cognitive fluctuations. Diagnosis is often either missed or delayed due to physician lack of familiarity with characteristic features, the inability of structural MRI to detect a pathological signature for this condition, and the lack of healthcare provider access to "indicative biomarkers" that are either unavailable at community clinics or costly due to lack of insurance coverage. The role of resting state function MRI (rs-fMRI) as a diagnostic biomarker has been underexplored in this disease. We propose using a novel cloud-based automated imaging software processing program that identifies abnormal brain networks or connectomes using resting state functional MRI (rs-fMRI) and data from the Human Connectome Project (HCP). Furthermore, the imaging protocol to capture this data is relatively short (15 minutes) and can be performed at most imaging centers, lending potential clinical applicability to this study. We intend to study dysfunctional large scale brain networks (LSBNs) in DLB by comparing rs-fMRI imaging data in this population with cognitively normal (CN) and mild Alzheimer's disease (AD) subjects from the Alzheimer's Disease Neuroimaging Initiative (ADNI)-2/3 database.

Description:

Omniscient, a for-profit, Sydney, Australia-based company, created the cloud-based software Infinitome, a program that utilizes data from the Human Connectome Project (HCP) together with machine learning to analyze diffusion tensor and resting-state fMRI imaging data from remote sites. The foundation for this imaging tool is based upon the HCP atlas, which has also informed prior publications from our group, including the Connectomic Atlas of the Human Cerebrum (Baker, Burks, Briggs, Conner, et al. 2018). The Infinitome program creates a subject specific version of the Human Connectome Project Multimodal Parcellation (HCP-MMP1) atlas using diffusion tractography. Analytics are performed on both diffusion tensor imaging and rs-fMRI. Outlier detection using a tangent space connectivity matrix is performed by comparing results with a subset of 300 normal HCP subject fMRI samples to determine the range of normal correlations for each regions of interest in a large scale brain network which include:

1. Locus coeruleus vs. Nucleus basalis of Meynert

2. Locus coeruelus vs. Intralaminar nucleus of the thalamus

3. Nucleus basalis of Meynert vs. Intralaminar nuclei of the thalamus

4. FST in the vs. Area PH in the lateral occipital lobe

5. Substantia nigra vs. Caudate nucleus Clinical Measures will be correlated with functional connectivity scores to identify relationship between clinical symptoms and large scale brain networks in DLB

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: June 19, 2023
• Est. primary completion date: February 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age 40-90 years

• Established DLB diagnosis

• Mini mental status exam (MMSE) >15

Exclusion Criteria:

• Other forms of dementia including, but not limited to Alzheimer's dementia, frontotemporal dementia, vascular dementia, normal pressure hydrocephalus (NPH), etc,

• Inability to tolerate brain function magnetic resonance imaging (fMRI)

• Risk of brain fMRI due to implants or metal.

Related Conditions & MeSH terms

• Dementia
• Dementia With Lewy Bodies
• Lewy Body Disease

Intervention

Procedure:
• Infinitome
All patients will have rs-FMRI images analyzed with the Infinitome cloud-based software processing program.

Locations

Country	Name	City	State
United States	HealthPartners Neuroscience Center	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
HealthPartners Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional connectivity scores between pairs of large scale brain networks.	Identify functional connectivity scores between pairs of large scale brain networks as determined by connectomic analysis using rs-fMRI Infinitome software in order to compare functional connectivity scores between groups. Range [-1,1]. Higher score indicates greater connectivity.; Functional connectivity scores between: Locus coeruleus vs. Nucleus basalis of Meynert; Locus coeruelus vs. Intralaminar nucleus of the thalamus; Nucleus basalis of Meynert vs. Intralaminar nuclei of the thalamus; Area FST vs. Area PH in the anterior inferior lateral occipital lobe; Substantia nigra vs. Caudate nucleus	Baseline
Secondary	Correlation of clinical measures and functional connectivity scores	Clinical Measures will be correlated with functional connectivity scores to identify relationship between clinical symptoms and large scale brain networks in DLB . Range [-1,1]. Higher score indicates greater connectivity.; Correlation of: Mini Mental State Examination; Wechsler Memory Scale -Revised (WMS-R) Logical Memory A; Alzheimer's Disease Assessment Scale - Cognitive (ADAS-COG) 13; Boston Naming Test; Verbal Fluency; WMS-R Digit Span; American National Reading Test; Rey Auditory Verbal Learning Test; Trail Making Test A/B; Clock Drawing Test; Neuropsychiatric Inventory Questionnaire; Functional Assessment Questionnaire	Baseline